Development · 18 Aug 2026

The US Food and Drug Administration granted final approval to Lupin Limited for an Abbreviated New Drug Application for pitolisant tablets, a generic bioequivalent to Harmony Biosciences' WAKIX indicated for treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

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The record

indiatimes.com17 Aug 2026

A single act of reporting so far, corroborating sources join this record as they publish.

Lupin

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